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Combination Therapy of HAIC and HLX10 and HLX04 in HCC With Major Portal Vein Tumor Thrombosis

NCT04947826 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-07-01

No results posted yet for this study

Summary

This is a randomized, double-blinded, controlled, phase II study. The purpose is to evaluate efficacy and safety of the combination therapy of HAIC (Hepatic arterial infusion chemotherapy) with HLX10 (PD-1 antibody) and HLX04 (VEGF antibody) compared with HAIC and placebo in patients with hepatocellular carcinoma with major portal vein tumor thrombosis.

Conditions

  • Hepatocellular Carcinoma With Major Portal Vein Thrombosis

Interventions

PROCEDURE

HAIC (Hepatic arterial infusion chemotherapy)

For the HAIC procedure, a 5F catheter was introduced using the Seldinger technique through the femoral artery or the radial artery. Then, angiographic surveys of the celiac trunk and superior mesenteric artery were performed. According to tumor size, location, and arterial supply, the catheter or a 2.7F microcatheter was advanced into the hepatic artery at the level of selective segmental, lobar, or whole liver. The catheter or microcatheter was connected to an external infusion pump. The following regimen of modified FOLFOX was administered: oxaliplatin, 85mg/m2 for 2 hours; leucovorin, 400mg/m2; and 5-fluorouracil, 2400mg/m2 for 44-46 hours. After HAIC treatment, the catheter or microcatheter, and the sheath were removed.

DRUG

HLX10 (PD-1 antibody)

PD-1 antibody with proven efficacy in advanced hepatocellular carcinoma

DRUG

HLX04 (VEGF antibody)

Combination of PD-1 antibody and VEGF antibody might promote the efficacy of HAIC in hepatocellular carcinoma with major portal vein thrombosis.

DRUG

Placebo

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2024-07-31
Completion
2024-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04947826 on ClinicalTrials.gov